What The J&J Faulty Hip Implant Saga Tells UsBloombergQuintOpinion
The faulty hip implant problem that could hurt an estimated several thousand Indian patients is the story of not just a faulty device and potentially criminal lapses by the manufacturer, but also government apathy, and the lack of appropriate legal remedies.
The Story So Far
DePuy, a company acquired by Johnson & Johnson in 1998, manufactured ASR hip implants between 2005-2010. It registered with India’s Central Drugs Standard Control Organization in October 2006.
In December 2009, the company was forced to recall the device in Australia due to a high rate of replacement surgeries. Despite the problems in Australia, DePuy applied for an import license in India for the device in January 2010, which it received the following month. 18 days after the grant of the import license, the company alerted the CDSCO to the problems in Australia.
In August 2010, DePuy decided to recall all implants in the U.S., issued a global communication to surgeons, and announced a ‘voluntary recall’ in India. By the end of the year, the company told CDSCO that in the intervening months, 15,829 ASR implants had been imported, 4,700 procedures had been performed.
Within two years, by 2012, DePuy’s India import license was cancelled due to the recall but the CDSCO issued a recall alert to hospitals, doctors, and patients only in December 2013. In that time, DePuy was settling with patients in Australia and the United States.
It was only in 2017 that the Indian government formed an expert committee to look into the problems with the device, the recall and the impact on patients. The committee report was made public earlier this week.
Of the 15,829 implants brought into India, 11,129 were reportedly unused but only 1,295 were returned. It’s not yet clear where the remaining are and if they were used on patients.
What Could The Government Have Done?
First, J&J, as the importer, is required to maintain a record of the sale of every implant and these implants can only be sold to entities (distributors and hospitals) which are licensed to purchase the implants. There ought to be a clear paper trail of every implant from the importer to the hospital where the implant surgery is performed. The government can easily trace every patient using the information from the doctors and hospitals.
The government is empowered to seek these records but has done nothing in this regard. The expert committee does not make any mention of the ‘missing’ 9,834 implants which J&J is unable to account for.
Secondly, the drug inspector is empowered to prosecute J&J and every distributor and hospital for not providing all the information on the implants it has sold. While the expert committee concludes that J&J did not provide this information, it does not hold doctors and hospitals which ‘sold’ these devices to patients, responsible for failure to provide this information.
While it is the duty of J&J to ensure recall of the implants that have not been sold to patients, hospitals and doctors are also complicit in this failure and ought to have been prosecuted in 2011.
Drug companies have been penalised by India’s National Pharmaceutical Pricing Authority for not recalling drugs to relabel them when the price for them has been reduced by the government but the government has done nothing over the last eight years to deal with the recall of a hip implant which is causing patients severe pain, even death. Reports indicate that J&J spent about Rs 15.96 crore but that seems to be for revision surgeries and diagnosis i.e., hospitals, doctors, and labs, and likely not to compensate patients, on the possible excuse that the patients can’t be traced.
Since the life of the hip implant is about 15 years, many of the patients who had these implants may be visiting doctors for a replacement very soon and this may be a window of opportunity to publicise the issue and give those patients a new lease of life. Will surgeons who did not help patients until now step up this time? Will the government inform all hospitals and surgeons so that they will comply this time, under the threat of prosecution for criminal negligence if they don’t?
Third, prosecution. The details of the First Information Report filed in December 2011 in the Mahim police station, Mumbai are unavailable.
Had the government diligently prosecuted J&J, the distributor, hospitals and doctors involved, in a criminal court for criminal negligence under Sections 336-338 of the Indian Penal Code, it could have claimed compensation for all the victims in that proceeding and the court under Section 357 of the Code of Criminal Procedure could grant compensation in the same manner as a civil court would.
This would mitigate the need for victims to each file separate cases in various civil courts around the country and suffer the torturous legal system against the might of a multinational corporation like J&J.
Regulatory System Failures
This incident highlights various significant flaws in our health regulatory system.
The regulation of medical devices has been lax and the Drugs and Cosmetics Act ignored the need for specific regulation of devices.
Expecting regulations which focussed on drugs and cosmetics to fit medical devices perfectly was just naive and it was plain laziness to ‘deem’ the definition of ‘drug’ to include medical devices.
There is no mention of defective devices when there is mention of spurious and adulterated drugs. How one would term a medical device either adulterated or spurious would be a challenge to the English language.
There is no provision for compensation to patients for defective medical devices in the Drugs and Cosmetics Act, only fines and prosecution which can be initiated only by the drug inspector or “recognised consumer associations”, not patients who are left to the mercy of general criminal and civil law. Surprisingly, provisions for compensation (a formula based on the Workmen’s Compensation Act for injuries in factories) has been introduced in the clinical trial rules which form a part of the Drugs and Cosmetics Act but not for victims of medical devices.
Schedule R-1 of the Drugs and Cosmetics Act which refers to standards (which includes shape, size, quality standards, etc) for medical devices only applies to condoms! While condoms are important and are perhaps the most widely sold and used medical devices, surely there are other devices that need the attention of the regulators.
While this issue has been addressed with the Medical Devices Rules, 2018, an exercise will need to be undertaken by policy experts to test how these new rules would have addressed the hip implant victims. Are we sure that there will be no more similar victims in India after these rules are implemented? The one significant feature of these rules is mandatory pharmacovigilance i.e, notification to the regulator within 15 days of serious adverse events from around the world.
So while this new provision can be significant, it is unlikely that it would have helped the hip implant victims.
What Can Patients Do?
1. Civil Suit: Representatives, as a group with similar issues and claims, can file a suit in a civil court. However, as we all know, it is unlikely that victims will achieve much given how slow and torturous our legal system is. Civil litigation, unlike claims in the consumer forum, can be an expensive process with high court fees in some cities.
2. Criminal Proceeding: Victims can file complaints in the nearest police station claiming criminal negligence by J&J, hospitals, and doctors.
They ought to claim that J&J was negligent in implementing the recall, the doctors and hospitals ought to have contacted the patients as soon as the Field Notice was issued in 2010 and ensured that all patients were given proper medical treatment.
3. Class Action: There have been reports in newspapers suggesting a claim of a breach of fiduciary duty by the board of directors and suggesting that the patients bring a class action claim in the National Company Law Tribunal. This seems quite a stretch and unlikely to succeed. While Section 166 of the Companies Act, 2013, requires every director to owe a duty to the community which may well include consumers but a failure to do so only results in prosecution and a maximum fine of Rs 5,00,000.
Oddly, independent directors have a specific duty to protect all stakeholders, which should include consumers.
4. Government Legislation: In a manner similar to its response to the 1984 Bhopal disaster, the government can act as parens patriae on behalf of all patients. With the learnings from the Bhopal case and the work done on the clinical trial rules for compensation, it would not be hard to have an adequate framework for fair compensation for medical victims. It is likely that J&J will agree on a lump sum settlement if the government presses for it.
The government could then collect and distribute compensation to the victims – a quicker and more efficacious solution than litigation.
This would also be a chance, as the expert committee recommends, to update the Drugs and Cosmetics Act for compensation to victims of drug and cosmetics companies. A start was made with compensation for clinical trial patients, based on the Workmen’s Compensation Act but patients currently have no recourse to drug companies except under the Consumer Protection Act, 1986.
The expert committee acknowledges the failings of the current legal system to compensate these victims but proceeds to establish a functional mechanism for compensation.
5. Consumer Forum: Patients will be in different cities but all those in the same city may well be heard in a consolidated manner. Alternately, patients can all choose to file their complaints in the State Consumer Forum in Mumbai where J&J conducts its business. Another option is for a number of patients could approach the National Consumer Redressal Forum in New Delhi with a claim of costs and compensation in excess of Rs 1 crore. The National Forum is empowered to hear all the matters together as a batch of related cases which have several common issues.
Doctors who performed the implant procedure could be made respondents so that their actions can be tested.
6. Join U.S. Mass Tort: Finally, Indian patients could join the mass tort actions (often mistakenly-termed class action) in the United States where a higher compensation is likely to be awarded than in India.
Besides, plaintiff claims lawyers act on a contingency fee basis, thereby reducing the litigation costs for the victims and speedier result than an Indian court could ever provide.
This is indeed one of those cases which could trigger a new regulatory and legal environment for patients in India. After all, every disaster highlights deficiencies and the hallmark of a compassionate society is what we learn from it.
Murali Neelakantan is an expert in healthcare laws.
The views expressed here are those of the author’s and do not necessarily represent the views of Bloomberg Quint or its editorial team.